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Formation Bio, an AI-driven pharmaceutical company revolutionizing drug development, today announced that Mikael Dolsten, MD, PhD, former Chief Scientific Officer and President, Pfizer Research & Development, has joined the company as a strategic advisor. In his role, Dolsten will serve as Chair of the Drug Picking Committee, Co-Chair of the Investment Advisory Committee, and Chair of Science, Technology, and Product Planning Committee.

Dolsten brings decades of experience in drug development and investment, having played a key role in Pfizer’s industry-leading R&D efforts, including the rapid development of the COVID-19 vaccine, the oral anti-viral drug Paxlovid, and many blockbuster therapies across a range of therapeutic areas. He concluded his tenure at Pfizer on March 1, 2025, after more than 15 years of leading the company’s R&D strategy, during which he oversaw the development and approval of more than 35 medicines and vaccines and moved over 100 drug candidates through clinical development, shaping global drug innovation at an unprecedented scale.

At Formation Bio, he will focus on leading asset selection and drug development strategy, leveraging his extensive global network to identify high-potential assets. More broadly, he will also provide strategic guidance on the company’s AI initiatives, advising on the development of its AI platform for asset search, evaluation, and deep research on drug targets to enhance decision-making and accelerate pipeline growth.

“The pharmaceutical industry is at an inflection point, where AI is shifting from an experimental tool to a core driver of efficiency and innovation in drug development,” said Mikael Dolsten. “I have seen firsthand how AI has transformed drug discovery, yet development remains a critical bottleneck. Formation Bio is leading the charge in applying AI to streamline and accelerate this process, creating a new paradigm for pharma. Their ability to integrate AI at every stage—from asset selection to clinical execution—positions them to fundamentally reshape the industry. I am excited to work alongside this exceptional team to help bring more innovative therapies to patients faster and more efficiently than ever before.”

Formation Bio seamlessly integrates AI across many facets of the drug development lifecycle—from asset sourcing and evaluation to clinical trial execution—aiming to enhance efficiency, reduce costs, and improve success rates. Currently, Formation Bio's pipeline includes four majority-owned assets, with a goal to expand to 10-15 assets over the next 3-5 years.

“Mikael is one of the most respected minds in pharmaceutical R&D, with a track record of shaping some of the most important drug advancements of our time,” said Ben Liu, Co-Founder & CEO of Formation Bio. “His scientific leadership, strategic vision, and ability to bridge cutting-edge research with real-world applications have made a lasting impact on the industry. His involvement with Formation Bio reflects his belief in the transformative power of AI in drug development, and we are incredibly fortunate to have his expertise on board.”

Formation Bio is an AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients. For more information, please visit www.formation.bio.

This press release contains forward-looking statements about Formation Bio's business prospects, pipeline development, and asset expansion plans. These statements are based on current expectations and beliefs but are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Formation Bio undertakes no obligation to update these forward-looking statements as a result of new information or future events.

Mikael Dolsten, MD, PhD, former Chief Scientific Officer and President, Pfizer Research & Development will serve as Formation Bio's Chair of the Drug Picking Committee, Co-Chair of the Investment Advisory Committee, and Chair of Science, Technology, and Product Planning Committee

Former Pfizer R&D Chief Mikael Dolsten Joins Formation Bio

 - Today, Formation Bio, together with OpenAI and Sanofi, introduced Muse, an advanced AI-powered tool developed to accelerate and improve drug development by optimizing patient recruitment for clinical trials. Muse is the first outcome of the collaboration between the three companies, which aims to combine their pharma expertise and AI models to accelerate drug development and ultimately speed up breakthrough therapies to patients.

Patient recruitment is a critical yet often slow and costly aspect of clinical development. It is estimated that less than 10% of patients participate in clinical trials for different reasons, including the fact that they are never invited or informed about the opportunity. This low participation rate causes delays that directly impact how quickly new medicine can reach patients. Muse, the first AI application of its kind in the pharmaceutical industry, aims to shorten patient recruitment timelines by accelerating recruitment strategy and content creation from a typical timeline of months to just minutes.

to analyze extensive scientific literature, real world evidence and unique insights on diseases and patient populations, delivering comprehensive research, strategic opportunities, and faster preparation of patient recruitment strategies - accomplishing what typically requires large teams of experts and multiple layers of manual review with a single AI tool. First, it compiles in-depth research on diseases, patient demographics, and the competitive landscape. It then identifies optimal patient profiles and recruitment strategies to include diverse populations across therapeutic areas. Finally, Muse auto-generates high-quality recruitment materials and pre-screening questionnaires, tailored to specific patient subgroups and adaptable for various channels, languages, and styles.

Ben Liu, Co-Founder & CEO, Formation Bio:

 "AI presents a tremendous opportunity to transform drug development, ultimately enhancing both efficiency and outcomes. At scale, this AI-driven development approach can accelerate the delivery of new medicines and reshape healthcare worldwide. Muse is just the start—one of the many AI innovations we’re building for drug development.”

Developed jointly by the three companies leveraging multiple OpenAI models, Muse

is designed for use across a wide range of therapeutic areas. Both Sanofi and Formation Bio plan to implement Muse in upcoming clinical trials, with Sanofi leading the initial deployment in Phase 3 studies for multiple sclerosis (MS). For this rollout, Sanofi will provide data and expertise on MS, leveraging its deep experience in delivering innovative treatments to support patients affected by this debilitating condition.

Emmanuel Frenehard, Chief Digital Officer, Sanofi: 

“By leveraging advanced AI capabilities, we can not only enhance recruitment efficiency but also potentially bring new treatments to patients faster. The development of Muse, a result of our ongoing collaboration with OpenAI and Formation Bio, represents another proof point in Sanofi’s journey to becoming the first pharma company powered by AI at scale.”

Muse develops tailored strategies and materials designed for diverse patient populations, including historically underrepresented groups, in order to enhance inclusiveness and representation in clinical trials. This approach can expand participation and ultimately capture broader trial data, contributing to more reliable, generalizable insights that better reflect the needs of all patients.

Additionally, Muse includes an LLM agent that incorporates Institutional Review Board (IRB) and regulatory guidelines, aiming to automatically generate high-quality materials that keep compliance best practices in mind. This feature, when combined with human experts in the loop, reduces the risk of regulatory setbacks, promoting smoother, more efficient trial progression.

AI safety and data privacy are embedded throughout Muse’s development and deployment, reflecting all three companies' commitment to the responsible use of AI. Muse relies on research publications and other public and proprietary data sources, none of which contain personally identifiable information (PII).

"We believe AI can accelerate drug development, bringing new treatments to patients more quickly. This first product from our collaboration with Sanofi and Formation Bio is just the beginning, and we can't wait to see the impact it will have."

Formation Bio is a tech-driven, AI-native pharma company differentiated by radically more efficient drug development. Formation Bio has built technology and AI platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies and biotechs to develop programs past clinical proof of concept and beyond, leveraging their proprietary tech and AI capabilities, ultimately helping to bring new medicines to patients.

OpenAI is an AI research and deployment company. Its mission is to ensure that artificial general intelligence benefits all of humanity. Last month, OpenAI announced it would be opening an office in France, so it can better support French developers, businesses and civic organizations so they can benefit from this transformative technology.

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Formation Bio collaborates with Sanofi and OpenAI to Introduce Muse, a first of its kind AI tool to accelerate patient recruitment in drug development.

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Former Pfizer R&D Chief Mikael Dolsten Joins Formation Bio

Introducing Muse